ABSTRACT
INTRODUCTION: Accurate evaluation of ADAMTS13 activity is required for the diagnosis and clinical management of thrombotic microangiopathies, and commercial kits are available for routine laboratory use. METHODS: Our study compares the results from Technoclone (Technoclone GmbH, Austria) activity and Inhibitor kits with specialist laboratory reference methods (FRETS and ELISA IgG) and the impact of transporting frozen samples and comparison of results. RESULTS: This multicentre study identified differences in Technoclone activity results compared to specialist testing, which could potentially impact diagnosis. A change in the commercial kit during the study period appears to have rectified the detection levels. Frozen samples provided comparable results between sites. CONCLUSION: With close attention to normal ranges, commercial kits are suitable for use in the clinical diagnosis of thrombotic microangiopathies and frozen transportation of samples between sites is a suitable approach. However, a robust external quality control system is essential to provide an independent evaluation of changes in kit production.
Subject(s)
ADAMTS13 Protein/antagonists & inhibitors , ADAMTS13 Protein/blood , Protease Inhibitors/chemistry , Thrombotic Microangiopathies/blood , ADAMTS13 Protein/analysis , Female , Humans , Male , Reagent Kits, DiagnosticABSTRACT
An optimised water-in-oil-in-water double emulsion process for the microencapsulation of plasmid DNA in poly(D,L-lactic-co-glycolic acid) (PLGA) was used to prepare microparticles from a range of different PLGA formulations. This process has been developed using pharmaceutically accepted solvents and is potentially scaleable. Incorporation of plasmid DNA in the microparticles of up to 11 microg/mg was obtained and the retention of plasmid DNA integrity was considerably greater than previously reported. Microparticle structure was determined, by scanning electron microscopy, to be hollow and size distribution characteristics were found to be independent of polymer formulation. The ability to vary the plasmid DNA release profile by changing the PLGA formulation and polymer concentration used in the encapsulation process was also demonstrated. This ability to control the release profile of the microparticles was shown to be especially important as the physical integrity of the encapsulated plasmid DNA was found to deteriorate with extended release times in vitro.
Subject(s)
DNA/administration & dosage , Drug Delivery Systems , Lactic Acid , Plasmids/genetics , Polyglycolic Acid , Polymers , Drug Compounding , Electrophoresis, Agar Gel , Microscopy, Electron, Scanning , Microspheres , Polylactic Acid-Polyglycolic Acid Copolymer , ViscosityABSTRACT
BACKGROUND: Symptoms of chronic idiopathic urticaria (CIU) include relentless itching and painful wheals, which can be physically and psychologically debilitating. Half of all patients with urticaria have angioedema, which is often disfiguring. OBJECTIVE: To evaluate the safety and efficacy of fexofenadine HCl for the treatment of CIU symptoms. METHODS: In this 4-week, multicenter, placebo-controlled study, 439 patients with moderate to severe pruritus and urticaria received 1 of 4 oral doses of fexofenadine HCl (20, 60, 120, or 240 mg twice a day) or placebo. Patients reflectively assessed (over the previous 12 hours) the severity of pruritus, the number of wheals, and the interference with sleep (7 AM) and normal activities (7 PM) due to urticaria. Efficacy measures included a change from baseline of daily mean pruritus score (MPS), daily mean number of wheals (MNW) score, daily mean total symptom score (MTSS) (ie, the sum of the wheal and pruritus scores), and mean interference with sleep and daily activities due to urticaria. RESULTS: All 4 doses of fexofenadine were statistically superior to placebo (P =.0238) for MPS, MNW score, and MTSS. Patients receiving fexofenadine HCl also experienced significantly less interference with sleep and daily activities than patients receiving placebo (P =.0001). Efficacy results were similar in the 60-, 120-, and 240-mg groups and were quantitatively better than those in the 20-mg group. Adverse events were mild and occurred with similar incidence in all treatment groups. CONCLUSIONS: Fexofenadine HCl is well tolerated and is statistically superior to placebo in reducing signs and symptoms of CIU and in ameliorating interference with sleep and daily activities due to urticaria. Doses of 60 mg twice a day or greater are most effective.
Subject(s)
Histamine H1 Antagonists/therapeutic use , Pruritus/drug therapy , Terfenadine/analogs & derivatives , Urticaria/drug therapy , Adolescent , Adult , Aged , Child , Chronic Disease , Double-Blind Method , Female , Histamine H1 Antagonists/adverse effects , Humans , Male , Middle Aged , Terfenadine/adverse effects , Terfenadine/therapeutic use , Treatment OutcomeABSTRACT
The Southern Arizona Regional Red Cross blood program offers preoperative autologous blood deposit to all patients and intraoperative autotransfusion services to all hospitals in the region. During a 5-year period, the amount of preoperatively deposited autologous blood and intraoperatively salvaged red cells available increased from 0.3 to 19.6 percent of the community's total collections. Further increases in the availability and use of autologous blood may be achieved by community-wide integration of services.